Synagis

Synagis

palivizumab

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Palivizumab
Indications/Uses
Prevention of serious lower resp tract disease caused by resp syncytial virus (RSV) in ped patients at high risk of RSV disease. Childn born at ≤35 wk of gestation & <6 mth at the onset of RSV season; <2 yr requiring treatment for bronchopulmonary dysplasia (BPD) w/in the last 6 mth; <2 yr w/ haemodynamically significant congenital heart disease.
Dosage/Direction for Use
IM Childn 15 mg/kg once a mth during anticipated periods of RSV risk in the community. Administer 1st dose prior to start of RSV season & subsequent doses given mthly throughout RSV season. Childn undergoing cardiac bypass Administer 15 mg/kg as soon as stable after surgery to ensure adequate palivizumab serum levels.
Contraindications
Hypersensitivity to palivizumab or other humanized monoclonal Abs.
Special Precautions
Allergic reactions including very rare anaphylaxis & anaphylactic shock. Discontinue use if severe hypersensitivity reaction occurs. Not indicated for adult usage. Patients w/ thrombocytopenia or any coagulation disorder. Moderate to severe acute infection or febrile illness. Pregnancy & lactation.
Adverse Reactions
Rash; pyrexia. Inj site reaction.
Drug Interactions
May interfere w/ immune-based RSV diagnostic tests (eg, antigen detection-based assays); inhibits virus replication in cell culture & may also interfere w/ viral culture assays.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J06BD01 - palivizumab ; Belongs to the class of antiviral monoclonal antibodies. Used in passive immunizations.
Presentation/Packing
Form
Synagis soln for inj 100 mg/mL
Packing/Price
(single-use) 1's
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